31 July 2024 - Achieve Life Sciences announced today that the US FDA has granted breakthrough therapy designation for cytisinicline for nicotine e-cigarette, or vaping, cessation.
Achieve’s Phase 2 ORCA-V1 trial, recently published in the JAMA Internal Medicine, evaluated the efficacy and safety of 3 mg cytisinicline dosed three times daily for 12 weeks compared to placebo in 160 adults who used nicotine e-cigarettes, did not smoke, and wanted to quit vaping.